Important aspects of plasmid DNA purity are explained in the new article "Assessing pDNA Purity For Cell & Gene Therapies" by our senior analytical consultant Brian Glass. The application of conventional development methods to the difficulties encountered in producing gene therapy products is examined in this article. Brian highlights the upcoming USP 1040 chapter and offers advice on developing successful control measures for plasmid DNA, a crucial building block in the industry. https://hubs.ly/Q02zMqzM0
Pharmatech Associates, a USP company’s Post
More Relevant Posts
-
Gain insights on our take on how we solve three main challenges in advancing cell and gene therapies to clinic. Join Qian(Sarah) Li, PhD, EMBA to learn about how #plasmid DNA serves essential roles as critical materials for cell and gene therapy applications and various key considerations including emerging methods for yield improvement, characterization and quality control. #celltherapy #genetherapy
To view or add a comment, sign in
-
Learn about the intricacies of manufacturing in the cell and gene therapy space in this article in SupplyChainBrain written by my colleagues Dr Paolo Siciliano, Martin Sowden, Shanton Wilcox, and Harry Ustik. They break it down into 5 key areas of opportunity for manufacturers in this space. #AutologousCommercialCellTherapy #GeneTherapy #MedicalManufacturingChallenges
Five key manufacturing challenges in autologous commercial cell and gene therapies
paconsulting.smh.re
To view or add a comment, sign in
-
📢“The goal of the Cell and Gene Therapy Access Model is to increase access to innovative cell and gene therapies for people with Medicaid by making it easier for states to pay for these therapies,” Learn More ➡️https://lnkd.in/eNrGdZe4
To view or add a comment, sign in
-
R&D, Drug Development & Medical Affairs, Market Access Global Clinical Studies and Product Marketing Lifecycle Management across the Globe
insights on: 🔸 Considerations for Allogenic Cell and Gene Therapy Manufacturing 🔹 Start with the Right Cells 🔸 Design Your Process with Quality 🔹 Make Your Process Scalable Thanks to Mycenax for sharing this #pharmaceutical #regulatoryaffairs #cmoinsights #manufacturing #whitepaper #cancer #biotech #gmp #outsourcing
📗 New Whitepaper Release📗 💡 Tackling Cell and Gene Therapy Manufacturing Challenges ❗ Excited to share insights on: 🔸 Considerations for Allogenic Cell and Gene Therapy Manufacturing 🔹 Start with the Right Cells 🔸 Design Your Process with Quality 🔹 Make Your Process Scalable Know more: https://lnkd.in/gkhurYB7 Contact us: info@mycenax.com.tw #Mycenax #CGT #CellTherapy #GeneTherapy #Allogeneic #ManufacturingSuccess #RoosterBio #MSC-EV
To view or add a comment, sign in
-
With the Casgevy and Lyfgenia regulatory approvals breaking remarkable new ground in the treatment of sickle cell disease, SelectScience® is putting the spotlight on the opportunities and challenges in cell and gene therapy. Dive into this #AcceleratingScience feature #CGT #AAV #personalisedmedicine #genetherapies #cellandgenetherapy
Exciting news! Our highly anticipated Cell and Gene Therapy Accelerating Science feature is now live. Dive into the future of this field, exploring revolutionary breakthroughs and insights. #Celltherapy #Genetherapy #CGT #AcceleratingScience
Visit the special feature
selectscience.net
To view or add a comment, sign in
-
Battelle’s Anthony Duong delivered his #PODD2023 talk track, "New Perspectives on Nanoparticle Platforms for Navigating Genetic Nanomedicine Through Regulatory Pathways" this week. Our experts will be in booth 4 to continue the conversation and chat about our capabilities in drug delivery. To find out more about how Battelle is advancing the field of gene therapy, read our blog “High-throughput platform propels gene editing therapy research.” https://okt.to/CfDV9y
To view or add a comment, sign in
-
Navigating the evolving landscape of approved cell and gene therapies poses a challenge for the drug development community. Discover insights on aligning expectations and implementing effective bioanalytical strategies in our latest eBook. For more in-depth knowledge, explore our new Cell and Gene Therapy Accelerating Science Feature: https://lnkd.in/ea6_b8_v #genetherapy, #celltherapy, and #drugdevelopment. #AAPS #BiotechInsights
Download Your Exclusive SelectScience How-to-Buy eBook
To view or add a comment, sign in
-
Overcoming manufacturing, delivery, and affordability challenges for cell and gene therapies in the Asia-Pacific region https://lnkd.in/efNFUyFj learnings from local case studies. In this update, we share two case studies that explore how local innovators in the cell and gene therapy space in Asia-Pacific are addressing some of the major challenges for access in the region. https://lnkd.in/efNFUyFj #MarketAccess #HEOR #WeAreAvalereHealth
To view or add a comment, sign in
-
Interested to learn about the role of AAVs in gene therapy, how to manufacture AAVs, and moving from discovery to clinical and commercial manufacturing? Download our eBook to read about the considerations for your gene therapy manufacturing strategy!
Considerations for Your Gene Therapy Manufacturing Strategy - www.thermofisher.com
thermofisher.com
To view or add a comment, sign in
-
Our review was finally published!! In it we discuss the key considerations in selecting the appropriate animal model to use in the development of novel AAV gene therapies! Check out the review, and the capabilities of the non-clinical team at Cell and Gene Therapy Catapult below. #celltherapy #cellandgenetherapy #genetherapy #genetherapies #viralvectors #nonclinical #regulatoryaffairs #nonclinicalsafety #advancedtherapies #atmp #atmps #advancedtherapies #AAV
A review by the Cell and Gene Therapy Catapult has recently been published which provides guidance for therapy developers who are selecting an animal model to be used in non-clinical studies for AAV-based gene therapies. Find out more: https://buff.ly/3ZfT9pt #CellTherapy #GeneTherapy #AAV #AdvancedTherapies #ATMPs Mark Singh Parto Toofan, PhD Andrew B. Keith McLuckie
To view or add a comment, sign in
3,553 followers